Pilot Study: Geniculate Artery Embolization in Knee Osteoarthrosis.

Not Applicable

• Conditions: Osteoarthritis, Knee
• Interventions: Procedure: Geniculate Artery Embolization

• Registration Number: NCT04113681
• Lead Sponsor: Maisonneuve-Rosemont Hospital

Brief Summary

Geniculate Artery Embolization (GAE) has recently been described and studied as a palliative treatment for osteoarthrosis-related knee pain in patients un-eligible for surgical intervention. This treatment is based on the hypothesis that hypervascularization and associated increased nerve proliferation are possible sources of chronic pain following the morphological changes of osteoarthrosis. A large animal model has shown digital subtraction arteriography to be well correlated to both the histological findings of synovial inflammation and synovial contrast enhancement on magnetic resonance imaging. This embolization technique has also been applied to other regions of the musculoskeletal system including the elbow and the shoulder.

Detailed Description

Primary Objective Confirm the efficacy and the effectiveness of geniculate artery embolization for pain control in knee osteoarthrosis.

Secondary Objective Evaluate the effectiveness of geniculate artery embolization for pain control in specific population: young patients between 18 and 50 years old with advanced osteoarthritis (KL grade 3 or 4) for whom an orthopedic surgeon has deemed a total knee arthroplasty is not an appropriate therapy, and whom have failed conservative management for at least 6 months.

Investigators propose a prospective pilot study on 40 patients with osteoarthrosis.

Study Timeline

• Study Start: 2019-02-14
• Study First Submitted: 2019-10-01
• Study First Submitted QC: 2019-10-01
• Study First Posted: 2019-10-03
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-05
• Last Update Posted: 2021-03-08
• Primary Completion: 2021-06-01
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 18 years and older
• Moderate to severe knee pain (visual analog scale (VAS) > 70 mm)
• Pain refractory to at least 6 months of conservative therapies (anti-inflammatory drugs, or physical therapy, or muscle strengthening, or intra-articular injections)
• Localized pain on physical examination
• Kellgren-Lawrence (KL) Score on knee X-Ray
• Patients 50 years old and over : grade 1, 2, 3 or 4
• 18-50 years old: KL grade 3 or 4

Exclusion Criteria

• Current local infection
• Life expectancy less than 6 months
• Known advanced atherosclerosis
• Rheumatoid or infectious arthritis
• Prior knee surgery
• Uncorrectable coagulopathy including international normalized ratio (INR) > 1.5 or platelets < 50,000
• Iodine allergy
• Renal dysfunction as defined by GFR < 60ml/min obtained within the past 30 days.
• Diabetic patient
• Previous embolization of the geniculate arteries during the last year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Geniculate Artery Embolization Arm	Geniculate Artery Embolization	Single-arm prospective study of geniculate artery embolization for symptomatic knee osteoarthritis

Primary Outcome Measures

Name	Time	Method
Pain control VAS	12 months	The pain intensity is assessed using VAS (horizontal line 100 mm in length). Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain".; * Expected mean VAS pre treatment: 7; * Expected mean VAS at 1, 3, 6 and 12 months: 3-4 (50% reduction)

Secondary Outcome Measures

Name	Time	Method
Radiological examinations	12 months	* Knee x-ray examinations; * Knee MRI (if a complication is suspected clinically); * Sustained response expected to be less likely with increased KL grade
Function	12 months	Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subcategories of pain (5 items), stiffness (2 items), and physical function (17 items). Individuals select the level of difficulty they have performing various tasks using a 5 points Likert scale (0=None, 1=Slightly, 3=Very, 4=Extremely). Results are scored with a total maximum score of 96. A higher score indicates more difficulty in each of the categories.; * Expected mean WOMAC score pre treatment: 50; * Expected mean WOMAC score at 1, 3, 6 and 12 months: 25 (50% reduction).

Trial Locations

Locations (1)

CIUSSS de l'Est-de-l'Île-de-Montréal, Installation Hopital Maisonneuve-Rosemont; 🇨🇦 Montréal, Quebec, Canada